Protection of biologically active molecules during radiation sterilization

A method of protecting a plurality of molecules of a biologically active molecule against a loss of biological activity from said plurality of molecules during a period of time in storage, comprising:

• (a) contacting the biologically active molecule in an aqueous solution with at least one soluble radioprotectant compound to obtain a radioprotected mixture prior to radiation sterilization;
• (b) drying the radioprotected mixture to obtain a dried radioprotected mixture;
• (c) radiation sterilizing the dried radioprotected mixture;
• and
• (d) storing the dried radioprotected mixture for a period of time to obtain a stored dried radioprotected mixture, wherein biological activity of the biologically active molecule in the stored dried radioprotected mixture after radiation sterilization and storage for said period of time is greater than biological activity of a control sample of the biologically active molecule that is dried, radiation sterilized without the radioprotectant compound present, and then stored for the period of time, and thereby protecting a plurality of molecules of the biologically active molecule against loss of biological activity during the period of time in storage.

A method of protecting biological activity of a biologically active molecule against radiation damage during radiation sterilization, comprising:

• (a) contacting the biologically active molecule in an aqueous solution with at least one soluble radioprotectant compound to obtain a radioprotected mixture prior to radiation sterilization;
• (b) drying the radioprotected mixture to obtain a dried radioprotected mixture;
• and
• (c) radiation sterilizing the dried radioprotected mixture to obtain a dried radiation sterilized radioprotected mixture, wherein, following rehydration of the dried radiation sterilized radioprotected mixture to obtain a rehydrated radiation sterilized radioprotected mixture, biological activity of the biologically active molecule in the radioprotected mixture after radiation sterilization is greater than biological activity of a control sample of the biologically active molecule that is radiation sterilized without the radioprotectant compound present, and thereby protecting biological activity of the biologically active molecule against radiation damage during radiation sterilization.

A method of protecting a plurality of molecules of a biologically active protein against a loss of biological activity from said plurality of molecules during a period of time in storage, comprising:

• (a) contacting the biologically active protein in an aqueous solution with at least one soluble radioprotectant compound to obtain a radioprotected mixture prior to radiation sterilization;
• (b) drying the radioprotected mixture to obtain a dried radioprotected mixture;
• (c) radiation sterilizing the dried radioprotected mixture;
• and
• (d) storing the dried radioprotected mixture for a period of time to obtain a stored dried radioprotected mixture, wherein biological activity of the biologically active protein in the stored dried radioprotected mixture after radiation sterilization and storage for said period of time is greater than biological activity of a control sample of the biologically active protein that is dried, radiation sterilized without the radioprotectant compound present, and then stored for the period of time, and thereby protecting a plurality of molecules of the biologically active protein against loss of biological activity during the period of time in storage.

A method of protecting biological activity of a biologically active protein against radiation damage during radiation sterilization, comprising:

• (a) contacting the biologically active protein in an aqueous solution with at least one soluble radioprotectant compound to obtain a radioprotected mixture prior to radiation sterilization;
• (b) drying the radioprotected mixture to obtain a dried radioprotected mixture;
• and
• (c) radiation sterilizing the dried radioprotected mixture to obtain a dried radiation sterilized radioprotected mixture, wherein, following rehydration of the dried radiation sterilized radioprotected mixture to obtain a rehydrated radiation sterilized radioprotected mixture, biological activity of the biologically active protein in the radioprotected mixture after radiation sterilization is greater than biological activity of a control sample of the biologically active protein that is radiation sterilized without the radioprotectant compound present, and thereby protecting biological activity of the biologically active protein against radiation damage during radiation sterilization.